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| Name | Class |
|---|---|
| Minia University | OTHER |
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Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.
Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA, but no RCT are available in the field. This randomized placebo-controlled clinical trial sought to evaluate whether the testicular sperm retrieval rate could result higher in NOA patients treated with follicle-stimulating hormone compared to placebo-treated NOA subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Experimental | Urofollitropin 150 IU ampoules three times a week for three months |
|
| Controls | Placebo Comparator | Placebo ampoules three times a week for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urofollitropin | Drug | Urofollitropin 75 IU 2 ampoules three times a week for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sperm retrieval rate (SRR) | testicular sperm retrieval rate after three months of urofollitropin treatment | three months |
| Measure | Description | Time Frame |
|---|---|---|
| IVF pregnancy rate | three to six months | |
| IVF implantation rate | three to six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ettore Caroppo, MD | Contact | +393479103660 | ecaroppo@teseo.it | |
| Craig Niederberger, MD | Contact | 3129969330 | craignied@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ettore Caroppo, MD | ASL Bari | Study Director |
| Craig Niederberger, MD | University at Illinois at Chicago UIC College of Medicine | Study Chair |
| Alayman Hussein, MD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18423236 | Background | Sussman EM, Chudnovsky A, Niederberger CS. Hormonal evaluation of the infertile male: has it evolved? Urol Clin North Am. 2008 May;35(2):147-55, vii. doi: 10.1016/j.ucl.2008.01.010. | |
| 11743304 | Background | Schoor RA, Elhanbly S, Niederberger CS, Ross LS. The role of testicular biopsy in the modern management of male infertility. J Urol. 2002 Jan;167(1):197-200. |
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| ID | Term |
|---|---|
| D053713 | Azoospermia |
| C564665 | Azoospermia, Nonobstructive |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D050477 | Urofollitropin |
| ID | Term |
|---|---|
| D008596 | Menotropins |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
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| Placebo | Other | Placebo ampoules administered three times a week for three months |
|
| El Minia University |
| Principal Investigator |
| 14667875 | Result | Caroppo E, Niederberger C, Vizziello GM, D'Amato G. Recombinant human follicle-stimulating hormone as a pretreatment for idiopathic oligoasthenoteratozoospermic patients undergoing intracytoplasmic sperm injection. Fertil Steril. 2003 Dec;80(6):1398-403. doi: 10.1016/s0015-0282(03)02202-7. |
| 24919724 | Result | Kato Y, Shiraishi K, Matsuyama H. Expression of testicular androgen receptor in non-obstructive azoospermia and its change after hormonal therapy. Andrology. 2014 Sep;2(5):734-40. doi: 10.1111/j.2047-2927.2014.00240.x. Epub 2014 Jun 12. |
| 22958644 | Result | Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7. |
| D052801 |
| Male Urogenital Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |